Status:
COMPLETED
Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects.
Detailed Description
Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often mak...
Eligibility Criteria
Inclusion
- Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to study entry
- Willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study
- Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration of the study
Exclusion
- Medical illness that may contribute to sexual dysfunction or affect steroid hormone levels
- Body mass index (BMI) greater than 30
- Elevated testosterone at screening
- History of seizure disorder
- Consumes more than 10 alcoholic beverages per week
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00611975
Start Date
October 1 2005
End Date
September 1 2008
Last Update
December 10 2020
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